Kornimate/medical-research-clean huggingface dataset:
study of the efficacy, safety and pharmacokinetics of pamiparib (bgb-290) in participants with advanced solid tumors

Conditions: Advanced High-grade Ovarian Cancer; Triple Negative Breast Cancer

Summary: this study is designed to evaluate the safety, tolerability, pkharmacokinetic profile and treatment effect of pamiparib in chinese participants with advanced high-grade ovarian cancer (including fallopian cancer or primary peritoneal cancer) and triple negative breast cancer in phase i, and to evaluate the efficacy and safety of pamiparib in chinese participants with recurrent epithelial ovarian cancer (including fallopian cancer or primary peritoneal cancer), harboring germline breast cancer susceptibility gene 1/gene 2 (brca1/2) mutation in phase ii.


Eligibility criteria:
key inclusion criteria: 1. participants have voluntarily agreed to participate by giving written informed consent. 2. age 18 years (including 18 years) on the day of signing informed consent. 3. participants meet the following eligibility criteria for the corresponding part of the study: 1) in phase 1 portion: the participants must have a histologically or cytologically confirmed locally advanced or metastatic cancer, either triple-negative breast cancer or epithelial, non-mucinous, high-grade ovarian cancer (including fallopian cancer, or primary peritoneal cancer), for which no effective standard therapy is available. 2) in phase 2 portion: participants who have histologically or cytologically confirmed high-grade epithelial ovarian cancer (including fallopian cancer or primary peritoneal cancer), harboring germline brca1/2 mutation 4. participants must have measurable disease as defined per the recist, version 1.1. 5. eastern cooperative oncology group (ecog) performance status of ≤1 key exclusion criteria: 1. participants who have been treated with chemotherapy, biologic therapy, immunotherapy, investigational agent, anti-cancer chinese medicine, or anticancer herbal remedies ≤ 14 days (or ≤5 half-lives, whichever is shorter) prior to starting study drug, or who have not adequately recovered from the side effects of such therapy. 2. participants who have undergone major surgery for any cause ≤ 4 weeks prior to starting study drug. participants must have adequately recovered from the previous treatment and have a stable clinical condition before entering the study. 3. participants who have undergone radiotherapy for any cause ≤ 14 days prior to starting study drug. participants must have adequately recovered from the previous treatment and have a stable clinical condition before entering the study. 4. untreated and/or active brain metastases. 5. prior therapies targeting poly (adp-ribose) polymerase (parp). note: other protocol defined inclusion/exclusion criteria may apply.
comparison of manual cardiopulmonary resuscitation (cpr) versus automatic cpr machine during ambulance transport.

Conditions: Cardiac Arrest; Cardiopulmonary Resuscitation

Summary: this is a randomized controlled prospective study which assigned patient to receive manual cpr or automatic cpr machine use. the quality and efficacy between manual cpr and machine cpr will be evaluated.


Eligibility criteria:
inclusion criteria: * non-traumatic out-of-hospital cardiac arrest patient in taipei distric * patients sent to national taiwan university hospital (ntuh) through jhongsiao emergency medical service (ems) team exclusion criteria: * younger than 15 years old * traumatic cardia arrest * patients not sent to ntuh by jhongsiao ems team

Keywords: resuscitation out-of-hospital cardiac arrest cardiac arrest cpr
oral metronomic capecitabine combined with pyrotinib in adc-treated her2-positive metastatic breast cancer

Conditions: HER2-positive Breast Cancer; Metastatic Breast Cancer

Summary: this is a prospective, open-label, multi-cohort, phase ii study to evaluate the efficacy and safety of oral metronomic capecitabine combined with pyrotinib in patients with her2-positive advanced breast cancer who had received prior anti-her2 adc drugs (including t-dxd, shr-a1811, t-dm1, etc.) before treatment.


Eligibility criteria:
inclusion criteria: 1. aged ≥18 and ≤75 years. 2. histologically or cytologically confirmed her2-positive metastatic breast cancer. 3. patients must have either experienced disease progression following anti-her2 antibody-drug conjugate (adc) therapy in the advanced/metastatic setting (including regimens containing shr-a1811, t-dxd, t-dm1, or other approved adcs) or discontinued prior anti-her2 adc treatment due to intolerable toxicity, financial constraints, or patient preference without evidence of disease progression. 4. ecog performance status of 0 to 2. 5. the functions of the main organs are basically normal 6. signed informed consent exclusion criteria: 1. prior treatment with a tki or capecitabine (or other fluoropyrimidine-based chemotherapy) in the advanced or metastatic setting. 2. known dihydropyrimidine dehydrogenase (dpd) deficiency. 3. pregnant or lactating patients; 4. malignancy (except basal cell carcinoma of the skin, which has been cured, and carcinoma in situ of the cervix) in the past 5 years; 5. history of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agent or accompanying supportive medications; 6. serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study or interfere with the study results 7. deemed by the investigator to be ineligible for participation in the study.
a study of pemetrexed and folic acid given before surgery (neoadjuvant treatment) to patients with rectal cancer.

Conditions: Rectal Neoplasms

Summary: the purpose of this study is to help answer the following research questions: if the study drug pemetrexed can help patients with rectal cancer; if molecular biological parameters are correlated respectively changing due to cytotoxic treatment with pemetrexed; to evaluate adverse events


Eligibility criteria:
inclusion criteria: * no prior therapy for rectal cancer * pathological/ cytological diagnosis of adenocarcinoma of the rectum. patients must have operable rectal cancer that is amenable to surgery. * adequate organ function * eastern cooperative oncology group (ecog) performance status 0 or 1 * signed informed consent * at least 18 years of age * surgically sterile, postmenopausal (women) or compliant with a medically approved contraceptive regimen during and for 6 months after the treatment. exclusion criteria: * concurrent administration of any other anti-tumor therapy * treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry * serious concomitant systemic disorders * previously completed or withdrawn from this study * pregnant or breast-feeding * second primary malignancy * history of significant neurological or mental disorder, including seizures or dementia * inability to interrupt aspirin or other nonsteroidal anto-inflammatory drugs (nsaids) * presence of clinically relevant third space fluid collections that cannot be controlled by drainage or other procedure prior to the study entry * inability or unwillingness to take folic acid, vitamin b12 or dexamethasone
optimizing protocols for the individual patient in ct pulmonary angiography.

Conditions: Pulmonary Embolism

Summary: computed tomographic pulmonary angiography (ctpa) is considered the gold standard for the diagnosis of pulmonary embolism (pe). pe is a potentially fatal disease in which a thrombus is lodged into a pulmonary artery blocking blood flow and potentially leading to respiratory distress, acute right cardiac failure or death. therefore early and correct diagnosis is crucial. the diagnostic and clinical value of ctpa has already been firmly substantiated. unfortunately up to 7.3% of pe scans are still deemed to be non-diagnostic, for example due to insufficient contrast enhancement in the target arteries. therefore future research should focus on two important aspects of ct imaging. on the one hand optimal enhancement for the individual patient, on the other hand preventing additional risk of ct imaging - namely contrast induced nephropathy (cin) and radiation risk. thus the purpose of our study will be to optimize radiation dose settings (e.g. tube voltage, tube current) and cm application for the individual patient in ctpa.


Eligibility criteria:
inclusion criteria: * suspicion of pulmonary embolism exclusion criteria: * severe allergy against iopromide or any of the ingredients, previous severe cm reaction (according to current esur guidelines), renal insufficiency, pregnancy

Keywords: pulmonary embolism multidetector computed tomography radiation dosage contrast media individualized medicine
a serious game to rehabilitate gaze stability in children with vestibular deficit

Conditions: Vestibular Disorder

Summary: since the early 2000s, vestibular rehabilitation has been proposed as a therapeutic tool to improve the balancing function and the various motor skills in children, in particular in children with hearing loss suffering from concomitant vestibular deficit. it has been demonstrated in adults with vestibular deficit that the fact of adding to the classic exercises on the control of balance per se and habituation, specific exercises of adaptation and substitution of the vestibulo-ocular reflex brought therapeutic benefit. these exercises, which are started in the presence of the physiotherapist and then continued by the patient himself at his home, aim to improve the stabilization of the gaze during head movements. in pediatrics, however, performing them is more difficult than conventional exercises, since their immediate interest is not well understood by the child, who may be reluctant to perform them. the present project aims to enrich the therapeutic offer by a pediatric rehabilitation method of eye stabilization sufficiently playful to win adherence to treatment, including in the absence of the physiotherapist when the child is at home.


Eligibility criteria:
inclusion criteria: * diagnosed with a vestibular disorder by the batteries of tests used in clinical routine. * supported by the multidisciplinary team of the audiology and otoneurological exploration department at the hfme * patient or parents able to understand the ins and outs of the study * no opposition from children and parents exclusion criteria: * associated visual sensorineural deficit * orthopedic or muscular disorder in the cervical spine

Keywords: vestibular disorder serious game vestibular rehabilitation
compare effects of ultrasound therapy with high intensity laser therapy for treatment of lumbar disc herniation.

Conditions: Disk Herniated Lumbar

Summary: the aim of this study is to assess and compare the effects of ultrasound therapy and high intensity laser therapy, as the treatment option in case of lumbar disc herniation.

a randomized control trail will be conducted in safi teaching hospital near riphah international university, after approval of synopsis. to evaluate the comparison and effect of ultrasound therapy and high intensity laser therapy, 30 patients will be randomly assigned to high intensity laser therapy and ultrasound group. patients will be selected according to predefined inclusion and exclusion criteria. all the patients will be evaluated by computed tomography scan or magnetic resonance of lumbar spine. non-probability convenient sampling will be used to approach the patients in hospital. participants received 15 treatment session of high intensity laser therapy and ultrasound therapy over a period of three consecutive weeks (five days/week). two types of tools will be used to evaluate the find out the comparison of both groups visual analog scale and oswestry lowback pain disability questionnaire. data will be collected pre-treatment and post-treatment after 15 days. data will be analyzed by statistical package of social sciences version 20. difference between pre-treatment to post treatment between group will be analyzed by mann-whitney test, and within group difference will be analyzed by wilcoxon signed- rank test. the level of statistical significance will be set as p\< 0.05

Eligibility criteria:
inclusion criteria: * patient above age 18 and adult * patient with lumbar disc herniation diagnosed by mri * patient with no history of trauma and congenital abnormalities exclusion criteria: * if patient received anesthesia or corticosteroid within 4 week * patient with osteoporosis * patient with surgery or previous fracture of spinal stenosis * a history of acute trauma like osteoarthritis, myofascial pain syndrome, inflammatory rheumatic disease, systemic lupus erythematosus, diabetes mellitus type 1 and 2, thyroid dysfunction, obesity, pacemaker, neurological pathologies and anxious- depressive syndrome. * pregnant women

Keywords: high intensity laser therapy ultrasound therapy lumbar disc herniation. randomized control trial comparison
prospective assessment of conecct's classification for colorectal lesions.

Conditions: Colorectal Cancer

Summary: colorectal neoplastic lesion endoscopic characterization is a key element for histological predictive diagnostic value in conducting best appropriate resection choice. six classifications are necessary for fully correct characterization of different colorectal lesions. nonetheless, it can be tricky to use so many diagnostic tools with so many subcategories in the 6 existing classifications. that's why we decided to integrate all 6 existing classification validated factors in one single chart (conecct chart) allowing to both predict histological diagnostic value and to propose the best appropriate resection strategy. a previous prospective and multicentre study with all french medical residents in gastroenterology was conducted in order to prove pedagogic interest of this diagnostic tool. each student was asked to review 20 files with lesion pictures before and after lecture about conecct chart. this allowed us to prove that this diagnostic tool could significantly improve both histological predictive diagnostic value and therapeutic choice by french medical residents and gastroenterologists. our hypothesis is that conecct's classification can improve predictive diagnostic value of colorectal lesions in over 80% of cases. now that pedagogic interest of this diagnostic tool has been proven, we would like to carry out a larger prospective assessment in term of performance (value) of this instrument in order to both facilitate endoscopic characterization and allow a most appropriate diagnostic and therapeutic management of each colorectal lesion category.


Eligibility criteria:
* inclusion criteria : * both gender patients even or older than 18 years old * patient in need of proven diagnostic or therapeutic colonoscopy for colorectal lesion resection * patient with french health insurance coverage * obtaining of oral non opposition to research after loyal, clear and complete delivery of information * exclusion criteria : * previous attempt of lesion resection by mucosectomy * patient with a metastatic lesion diagnosed prior to colonoscopy * patient with no colorectal lesion * adenomatous or sessile serrated polyposis syndrome * patient with bowel chronic inflammatory disease

Keywords: diagnostic tool colorectal cancer therapeutic choice guidance conecct
capacitive-resistive energy transfer (cret) for the treatment of low back pain

Conditions: Low Back Pain

Summary: this retrospective observational study compares the effectiveness of two cret therapies in adults with physical dysfunction. it evaluates whether the uniq electrode fisiowarm 7.0 improves lumbar rom (schober test) and reduces pain (vas scores) more effectively than the classical methodology, with assessments at baseline (t0) and two weeks (t1).

the goal of this retrospective observational study is to compare the effectiveness of two cret therapy methodologies in adults (mean age ±sd: 51.23±16.89 for treated, 51.20±14.34 for control; m/f ratio: 42%m, 58%f for treated, 40%m, 60%f for control) experiencing physical dysfunction. the main questions it aims to answer are: * does treatment with the uniq electrode fisiowarm 7.0 improve range of motion (rom) as measured by the schober test more effectively than the classical methodology? * does treatment with the uniq electrode fisiowarm 7.0 reduce pain levels, as reported through vas scores, more effectively than the classical methodology? participants underwent therapy with either fisiowarm 7.0 or activ ct8 indiba® as per their group assignment. have their rom measured using the schober test at baseline (t0) and after two weeks (t1). report vas scores before therapy (t0) and after two weeks (t1) to assess pain levels.

Eligibility criteria:
inclusion criteria * age 18 years old or older * reported a visual analogic scale (vas) for pain equal or greater than 6 cm * a rom measured by schober test * naïve to cret therapy * non-concomitant physiotherapy treatment (e.g. diathermy, laser therapy etc..).
effects of cervical lidocaine spray on pain relief during manual vacuum aspiration

Conditions: Pain, Procedural; Lidocaine; Obstetric Surgical Procedures

Summary: this randomized control trial aim to evaluate the effectiveness of local lidocaine spray application to the cervix on the reducing of pain score during the manual vacuum aspiration

this is a double blinded, placebo controlled study which compose of two arms. the treatment group is the local lidocaine spray application to the cervix with the intravenous opioid. the control group is the the intravenous opioid with the placebo (normal saline) before the manual vacuum aspiration. the outcome is to compare the visual analog pain score during and after procedure.

Eligibility criteria:
inclusion criteria: * female ageed 20 years to 60 years who have an indication for manual vacuum adpiration under intraveneous analgesia exclusion criteria: * patient with allergic to lidocaine or history of allergic to lidocaine * patient with reproductive and urinary infection * patient with abnormal vital sign * patient with abnormal kidney and liver function test

Keywords: manual vacuum aspiration pain score lidocaine spray
early diabetes intervention program

Conditions: Type 2 Diabetes Mellitus

Summary: this is an evaluation of the effect of acarbose to delay worsening of fasting glucose control in early type 2 diabetes mellitus.

a double blind, randomized, placebo-controlled clinical trial of acarbose in subjects with type 2 diabetes (an fda-approved indication). subjects were identified who had diabetes by glucose tolerance test criteria but non-diabetic fasting glucose concentrations. treatment interventions were assessed for their ability to delay worsening of fasting glucose control.

Eligibility criteria:
inclusion criteria: * fasting plasma glucose \<140 mg/dl * 75 g ogtt 2hr glucose \>120 mg/dl * bmi \> 25 or history of gestational diabetes mellitus or family history of type 2 diabetes * age at least 25 years exclusion criteria: * cancer within 5 years * chronic infectious disease (hiv, hepatitis) * cvd event within 6 months * uncontrolled hypertension or requiring beta blockers or thiazide diuretics for control * elevated ast or alt * serum creatinine \>1.4 mg/dl (men) or \>1.3 mg/dl (women) * tg \>600 mg/dl * known glucosidase intolerance * inability to comply with protocol requirements.

Keywords: diabetes acarbose alphaglucosidase prevention
the pediatric spine foundation

Conditions: Chest Wall and Spinal Disorders

Summary: the pediatric spine foundation is a registry designed to assist spine surgeons to efficiently identify and track patients with chest wall and spinal disorders.

the pediatric spine foundation is a registry designed to assist spine surgeons to efficiently identify and track patients with chest wall and spinal disorders. the registry allows spine surgeons to participate in retrospective and prospective studies for specific spinal disorders.

Eligibility criteria:
inclusion criteria: * all patients 17 and under that are being treated at children's hospital colorado orthopaedic department for a chest wall deformity, spine deformity and/or spinal disorder. however, patients must be/have been 11 or under at their initial treatment/evaluation at children's hospital colorado to be included in this study. exclusion criteria: * enrollment in another spine registry
characterization of the melanoma-specific immune response

Conditions: Melanoma

Summary: the aim of this study is to study t-cells. blood will be collected and the samples will be used to generate t cell clones. two separate blood draws will be required at the maximum.

the aim of the study is to in-vitro characterize and expand t cells specific for melanoma-derived antigens. peripheral blood with be collected from 20 volunteers with biopsy proven melanoma and 10 age matched controls. blood will be collected prior to the initiation of chemotherapy. there will be no more than two blood draws per patient. most patients will receive a single blood draw; however, some participants may be asked to return for a single additional blood draw if investigators were unable to isolate melanoma-specific immune cells after the first blood draw. two separate blood draws will be the maximum. the interval between these blood draws will be a minimum of 3 months apart. blood samples will be used to determine the patient's hla haplotype via pcr and dna sequencing. after the patient's haplotype has been established melanoma-specific t cell clones will be generated from the peripheral blood samples and expanded in-vitro. these clones will then be assayed for specificity against commercially available melanoma cell lines. the t cell clones will also be assayed for reactivity to melanocyte differentiation antigens such as mart-1 and gp100. if the volunteer requires a palliative resection of a melanoma tumor then the patient's own tumor cells may also be used to test the specificity of the isolated t cell clones. all experiments will be conducted in-vitro.

Eligibility criteria:
inclusion criteria: * biopsy diagnosis of malignant melanoma * have had a biopsy diagnosis of malignant melanoma in the past exclusion criteria: * patients taking immunosuppressive medications

Keywords: melanoma malignant melanoma
multicenter randomized prospective trial comparing methotrexate alone or in combination with adalimumab in early arthritis

Conditions: Rheumatoid Arthritis; Arthritis

Summary: evaluation of two treatment modalities in early potentially severe early arthritis ( methotrexate alone or in combination with adalimumab)

patients: early ( less than 6 months), active ( das\>5.2),potentially severe ( leiden score\>6) study design:12 months, prospective , randomized, open study treatments: methotrexate at a weekly dose of 0.3mg/kilo alone or in combination with adalimumab 40 mg every the other week outcome measures: das over the 12 months

Eligibility criteria:
inclusion criteria: * early active potentially severe arthritis exclusion criteria: * contra indication of methotrexate or anti tnf

Keywords: early arthritis, methotrexate, adalimumab
development of human laboratory study model of cocaine relapse prevention ii - 1

Conditions: Cocaine-Related Disorders

Summary: to study of classical conditioning mechanisms associated with arousal, craving and cocaine use.

this is a single-site, double-blind, placebo-controlled crossover study of classical conditioning mechanisms associated with arousal, craving and cocaine use.

Eligibility criteria:
inclusion criteria: * be english-speaking volunteers who are cocaine dependent * be non-treatment seeking at the time of the study * meet dsm-iv criteria for cocaine dependence * have ecg showing normal sinus rhythm, normal conductivity, and non clinically significant arrhythmias * females must provide a negative pregnancy test and agree to use birth control * have baseline laboratory tests within normal limits exclusion criteria: * please contact site for more information